Status:
TERMINATED
Argatroban Versus Lepirudin in Critically Ill Patients
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Conditions:
Heparin Induced Thrombocytopenia (HIT)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy measured as life time of haemodialysis filters as compared ...
Detailed Description
Critically ill patients are at increased risk to develop deep vein thrombosis due to immobilisation and/or the underlying disease. Usually, heparin is used for anticoagulation in these patients. Howev...
Eligibility Criteria
Inclusion
- Thrombocytopenia suspicious for HIT with decrease in platelet count \>50% from baseline obtained at hospital admission
- 4 T´s score for HIT probability \>3 AND/OR positive ELISA for HIT
- Age ≥18 years
- Informed consent (if applicable)
Exclusion
- Transient thrombocytopenia due to intraoperative bleeding
- Active bleeding
- Intracranial operations
- Liver dysfunction with spontaneous aPTT\> 60 sec.
- History of adverse events or sensitivity against study drugs
- Pregnancy
- Age\<18 years
- Preexisting psychiatric/neurologic disorders with long-term inability to provide informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00798525
Start Date
January 1 2009
End Date
March 1 2012
Last Update
June 21 2012
Active Locations (1)
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1
Universitätsklinikum Düsseldorf Klinik für Anästhesiologie
Düsseldorf, Germany, 40225